(78 days)
No
The device description and performance studies focus on the mechanical and material properties of the trocar, with no mention of AI or ML.
No
The device is described as a tool to establish a path of entry for endoscopic instruments, which suggests it is used for access during procedures, not to treat a disease or condition itself.
No
Explanation: The device is described as a surgical instrument (trocar) for creating a path for other endoscopic instruments during minimally invasive procedures. Its intended use focuses on access and delivery, not on identifying, assessing, or monitoring a disease or condition.
No
The device description clearly outlines physical components (sleeve, needle, shield, tip) and performance studies focus on physical characteristics and animal testing, indicating a hardware-based medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a path of entry for endoscopic instruments" during surgical procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components and function of a surgical trocar, which is used to create a port for instruments during minimally invasive surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
Therefore, the Laport® Trocars are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
Product codes
GCJ
Device Description
The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, and gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Sterilization Validation Test in accordance with ISO 11737-1
- Shelf Life Validation Test
- Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Ethylene Oxide Sterilization residuals, Skin Sensitization, Systemic Toxicity, Irritation)
- Performance Tests: Appearance (Visual Inspection), Measurement (Inspecting dimensions using vernier calipers), Leakage (sample was put air in trocar sleeve with air pressure after close the valve, it should not be leaked), and Extraction (Appearance, pH, KMnO4, Evaporating residue, Heavy Metal, UV-vis Spectrum), and Non-Clinical (Animal) test using micropigs (Trocar Insertion & Extraction Test, Intraperitoneal Pressure Test, Convenience of performing laparoscope).
All the test results demonstrated that the subject device is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is centered on the page.
August 29, 2017
Sejong Medical Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc 690 Roosevelt Irvine, California 92620
Re: K171741
Trade/Device Name: Laport Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 5, 2017 Received: June 12, 2017
Dear Ms. Chung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171741
Device Name
Laport ®
Indications for Use (Describe)
The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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3
510(k) Summary
(K171741)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
1. Submitter/Applicant
Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880
Tel: +82-31-945-8191 Fax: +82-31-945-8190
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: Laport ®
- Common Name: Sterile Trocars for Endoscopic surgery ●
- Classification: Class II ●
- Classification regulation: 21 CFR 876.1500 ●
- . Product Code: GCJ
Predicate Devices: 4.
Primary Predicate Device: ENDOPATH® III Trocars (K032676) by Ethicon Edo-Surgery, Inc. Reference Predicate Deice: LAPORT (K092584) by MGB EndoskopischeGerate GmbH Berlin
510(k) Submission.
4
5. Description:
The Laport® Trocars are for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. The Laport® Trocars are consisting of a sleeve and needle in sizes ranging from 5 to 12 mm in diameter. There are three different needles: Safety, Optical and Bladeless Type. The Safety Type has a sharp flat-bladed tip and shield. The shield on the Safety Type needle is designed to cover the flat-bladed tip to protect internal structures from puncture once the abdominal or thoracic cavity has been entered. The Optical Type has a transparent tip for use with an endoscope to provide visualization for insertions. The Bladeless Type has a plastic tip which reduces hazards during puncture of abdominal cavity.
6. Indication for use:
The Laport® Trocars have applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instr uments.
Performance Data 7.
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- · Sterilization Validation Test in accordance with ISO11737-1
- · Shelf Life Validation Test
- · Biocompatibility Tests in accordance with ISO 10993
| Cytotoxicity | ISO 10993-5 |
|---|---|
| Ethylene Oxide Sterilization | |
| Residuals | ISO 10993-7 |
| Skin Sensitization | ISO 10993-10 |
| Systemic Toxicity | ISO 10993-11 |
| Irritation | ISO 10993-10 |
- · Performance Tests: Appearance, Measurement, Leakage, and Extraction, and Non-Clinical(Animal) test
| Test | Test Method |
|---|---|
| Appearance | Visual Inspection |
| Measurement | Inspecting dimensions using vernier calipers |
| Leakage | When the sample was put air in trocar sleeve |
| with air pressure after close the valve, it | |
| should not be leaked. | |
| Extraction Test | Appearance, pH, KMnO4, Evaporating |
5
| Non-Clinical(Animal)
| test using micropigs | residue, Heavy Metal, UV-vis Spectrum |
|---|---|
| Trocar Insertion & Extraction Test: | |
| The operator (expert veterinarian) scored the | |
| experience when the trocar was inserted into | |
| the abdominal cavity of animals and | |
| extracted according to pre-set scoring index. | |
| Insertion, Fixation, and Extraction were | |
| evaluated. | |
| Intraperitoneal Pressure Test: | |
| The time for intraperitoneal pressure to reach | |
| a certain mmHg was recorded. And the | |
| bubble test was performed to check the | |
| leakage of gas. Time to insufflation was | |
| evaluated. | |
| Convenience of performing laparoscope: | |
| The operator inserted the laparoscope | |
| thought the trocar needle of optical test | |
| devices and scored the convenience of | |
| performing laparoscope according to the | |
| scoring index demonstrated below. | |
| Visualization was also evaluated. |
All the test results demonstrated that the subject device is substantially equivalent to the predicate devices.
8. Basis for Substantial Equivalence
The subject device, Laport® incorporates the same intended use with the predicate devices. The subject device is composed of similar materials with the predicate devices. All the devices are similar in physical & mechanical properties. The differences between the subject device and the predicate device are universal seal and lip valve part. The subject device, Laport® has a universal seal that facilitate using a wide range of instruments from 5mm to 12mm.
We have performed the various performance tests, and the test results support that the subject device is substantially equivalent to the predicate devices.
9. Conclusion
Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the Laport® is substantially equivalent to the predicate devices.
510(k) Submission.